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Efficacy of Preoperative Re-education on Patients With an Anterior Cruciate Ligament Rupture

Efficacy of Preoperative Re-education on Patients With an Anterior Cruciate Ligament Rupture: a Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02505659
Acronym
PRELIG
Enrollment
80
Registered
2015-07-22
Start date
2015-02-28
Completion date
2017-01-31
Last updated
2016-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Rupture

Keywords

Anterior cruciate ligament rupture, Preoperative re-education, Knee functional performance, Anterior cruciate ligament surgery, Single-leg hop for distance test performance

Brief summary

Anterior cruciate ligament (ACR) rupture is a common lesion of sportsmen that leads to functional deficits which are difficult to overcome. To prevent from an unfavorable evolution, patients can either get a non-surgical treatment or an ACR surgery, which is very common. Knee functional performance level could impact on the postoperative outcome and it's of common knowledge that early re-education after an ACR rupture improves knee functioning. Patients with an ACR rupture enrolled in this study will be randomized either in an experimental group (with preoperative reeducation) or in a control group (without preoperative reeducation). Both groups will then have post-operative re-education (40 sessions) based on HAS recommendations. The main aim of this study is to assess the impact of preoperative re-education on knee functional performance 4 month after surgical reconstruction of an ACR. Secondary aims are to determine the impact of the 4-week preoperative re-education on knee functional performance after an ACR rupture, before surgery and 7 months after surgery. Functional performance, muscular strength, proprioception and anterior knee laxity will be measured at inclusion (V0), 4-5 days before surgery (V1), 4 month (V4M) and 7 months (V7M) after surgery. Lysholme-Tegner scoring and IKDC2000 questionnaire will be added to the previous assessments.

Detailed description

Anterior cruciate ligament (ACR) rupture is a common lesion of sportsmen that leads to functional deficits which are difficult to overcome. To prevent from an unfavorable evolution, patients can either get a non-surgical treatment or an ACR surgery, which is very common. Knee functional performance level could impact on the postoperative outcome and it's of common knowledge that early re-education after an ACR rupture improves knee functioning. Patients with an ACR rupture enrolled in this study will be randomized either in an experimental group (with preoperative reeducation) or in a control group (without preoperative reeducation). Both groups will then have post-operative re-education (40 sessions) based on HAS recommendations. The main aim of this study is to assess the impact of preoperative re-education on knee functional performance 4 month after surgical reconstruction of an ACR. Secondary aims are to determine the impact of the 4-week preoperative re-education on knee functional performance after an ACR rupture, before surgery and 7 months after surgery. Functional performance, muscular strength, proprioception and anterior knee laxity will be measured at inclusion (V0), 4-5 days before surgery (V1), 4 month (V4M) and 7 months (V7M) after surgery. Lysholme-Tegner scoring and IKDC2000 questionnaire will be added to the previous assessments.

Interventions

BEHAVIORALPreoperative re-education

Preoperative re-education (behavior): 8 re-education sessions of 30 to 40 minutes, 2 times a week, for 4 weeks

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Patients between 18 and 45 years old * Tegner physical activity level between 3 and 9 * Primary and unilateral rupture of anterior cruciate ligament, confirmed by MRI * patient available to carry out the preoperative re-education program

Exclusion criteria

* Complex lesion that would impede on preoperative re-education (posterior cruciate ligament, meniscal or chondral symptomatic lesion, fracture)/ * Neurologic or cardiorespiratory pathology contra-indicating preoperative re-education * Previous surgical treatment of the lower limbs or of the lumbar spine * Neuropathic or algodystrophic pain on the lower limbs

Design outcomes

Primary

MeasureTime frame
Functional performance as assessed by single-leg hop for distance test performanceat 4 months after ACR surgery.

Secondary

MeasureTime frameDescription
Dynamic balance as assessed by star excursion balance testat 4-month follow-up and 7-month follow-up compared to the initial visit and control group for:Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Quadriceps muscular strength as assessed by isokinetic test of quadriceps muscular strengthat 4-month follow-up and 7-month follow-up compared to the initial visit and control group for:Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Proprioception as assessed by repositioning knee testat 4-month follow-up and 7-month follow-up compared to the initial visit and control group for:Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Ability to return to high level athletics as assessed by single-leg hop for distance test performanceat 4-month follow-up and 7-month follow-up compared to the initial visit and control group for:Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Subjective knee evaluation as assessed by International Knee Documentation committee 2000 questionnaireat 4-month follow-up and 7-month follow-up compared to the initial visit and control group forAssessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Knee symptoms as assessed by Lysholme questionnaireat 4-month follow-up and 7-month follow-up compared to the initial visit and control group forAssessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Physical activity level as assessed by Tegner knee scoringat 4-month follow-up and 7-month follow-up compared to the initial visit and control group forAssessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Knee anterior stability as assessed by KT-1000at 4-month follow-up and 7-month follow-up compared to the initial visit and control group forAssessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026